Standardization of Breast Radiotherapy: Trial B - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
Standardization of Breast Radiotherapy: Trial B - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer
OBJECTIVES:
- Determine the benefits of radiotherapy schedules using fraction sizes larger than 2.0
Gy in terms of normal tissue responses, local-regional tumor control, quality of life,
and economic consequences in women prescribed postoperative radiotherapy for early
stage breast cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, type of surgery (mastectomy vs local excision), and breast boost (yes vs no).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive radiotherapy 5 times a week for 5 weeks for a total dose of 50
Gy.
- Arm II: Patients receive radiotherapy 5 times a week for 3 weeks for a total dose of 40
Gy.
A breast boost is recommended in both arms for patients with microscopic evidence of
invasive or in situ cancer at, or within 1 mm of, a resection margin. These patients receive
radiotherapy for 5 fractions in 1 week for a total boost dose of 10 Gy.
Quality of life is assessed at baseline and then at 6, 12, 24, and 60 months.
Patients are followed annually for up to 20 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1840 patients (920 per arm) will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive unilateral breast cancer
- T1-3, N0-1, M0 at presentation
- Complete macroscopic excision of tumor by breast conserving surgery or mastectomy
- No immediate breast reconstruction
- No requirement for axillary radiotherapy after greater than a Level 1 axillary
dissection or after greater than 10 lymph nodes have been removed
- Not enrolled on SECRAB or OSCAR trials
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
- Prior neoadjuvant, or primary medical, therapy is allowed provided subsequent surgery
confirms complete macroscopic excision of residual primary tumor
Biologic therapy:
- Not specified
Chemotherapy:
- At least 2 weeks since prior cytotoxic agents
- No concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
John R. Yarnold, MD, FRCR
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000067661
NCT ID:
NCT00005587
Start Date:
January 1999
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- Breast Neoplasms
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